FDA Approves ANDA077826 for Fenoldopam Mesylate Injection

The U.S. Food and Drug Administration (FDA) granted approval for an Abbreviated New Drug Application (ANDA) identified as ANDA077826. The application concerns fenoldopam mesylate, an injectable product intended for administration via injection. Key product details: - Brand name: Fenoldopam Mesylate - Dosage form: Injectable - Route of administration: Injection - Active ingredient: Fenoldopam mesylate, equivalent to 10 mg base per mL - Marketing status: Discontinued - Reference drug: No - Reference standard: No The submission was made by Teva Parenteral and classified as an original (ORIG) submission. The FDA’s review document for this application is available at https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/077826Orig1s000.pdf. The submission status is listed as Approved (AP) with a status date of March 7 2007. For full details, refer to the FDA’s official documentation linked above.